Xamic® - Renata Limited

Xamic
®
Tranexamic Acid
COMPOSITION:
Each capsule contains 500 mg tranexamic acid B. P.
Each ampoule contains 500 mg/5ml tranexamic acid B. P.
DESCRIPTION:
Xamic ® is a preparation of tranexamic acid.It is a
substance endowed with a strong antifibrinolytic action
and both in - vivo and in-vitro it has proved to be from 5
to10 times more active than aminocaproic acid,
depending on the test. The antihemorrhagic action of
tranexamic acid is essentially due to an inhibition of the
plasminogen activation of both exogenous activators like
streptokinase and endogenous ones like urokinase and
the plasminogen tissue activator. This fact is particularly
important for the clinical use of Xamic ®, because it
ensures an antihemorrhagic activity with an
antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Xamic ® is extremely low and
chronic toxicity almost non-existent.
Xamic ® is well absorbed by oral route and the effect is
already seen 15-30 minutes after administration.
It is excreted mainly by renal route but more slowly than
aminocaproic acid.
These features make the Xamic ® effect more lasting
than that of aminocaproic acid. Considerably lower
single doses of Xamic ® can thus be administered at
greater intervals without the drug plasma levels dropping
to inefficient levels of antifibrinolytic activity between one
dose and the other.
Xamic ® at therapeutic doses does not interfere with
clotting processes and even a prolonged administration
has not been seen to be accompanied by any tendency
to thrombophilia.
INDICATIONS:
In medicine
Prophylaxis and therapy of hemophtoes, digestive
hemorrhages, hemorrhagic syndromes in leukaemia,
cirrhosis and hemophilia, thrombocytopoenic purpura,
accidents during thrombolytic therapy and transfusion.
In surgery
Prophylaxis and antihemorrhagic therapy during
operations of any type and nature and particularly in
pulmonary, cardiovascular and abdominal surgery and
post-operative and traumatic shock.
In urology
Prophylaxis and antihemorrhagic therapy of prostatic,
vesical and renal surgery. Hematurias.
In obstetrics
Prophylaxis and therapy of post-partum and puerperium
hemorrhages, hemorrhagic metropathies, functional
menometrorrhagias, apparently primitive or symptomatic
menorrhagias of diffuse hemorrhagic syndrome.
Primitive
hyperfibrinolysis
(abruptio
placentae,
premature placenta detachment).
In otorhinolaryngology
Prophylaxis and antihemorrhagic therapy during
tonsillectomy, specialist surgery generally, epistaxis.
In stomatology
Prophylaxis and antihemorrhagic therapy
maxillofacial operations, tooth extractions.
during
DOSAGE AND ADMINISTRATION:
Adults: For prophylaxis the mean recommended daily
doses are 0.5-1g orally, 500 mg by parenteral
(intravenous or intramuscular) route, except in cases of
administration of different dosages.
For therapy of hemorrhagic manifestations, oral dose
increases to 1-3g given in divided doses: in cases of
particular seriousness and urgency , begin by injecting
an ampoule slowly by intravenous route, and administer
the necessary subsequent doses orally.
Children: For prophylaxis, for every kg of body weight
from 5 to 10 mg are administered daily orally in divided
doses, for therapeutic purposes the oral doses are
doubled (from 10 to 20 mg/kg), while the intravenous and
intramuscular treatment is begun with 10mg/kg (=0.5 ml
every 5 kg) by slow intravenous route, continuing the oral
administration up to the required dose.
Where it is more convenient (e.g. in small babies) the
ampoules, diluted in a little sweetened water, may be
orally administrated instead of the capsule.
WARNINGS:
Xamic ® should be used in cases where there is
hyperfibrinolysis. The prophylactic treatment must begin
24 hours before the operation and continue until 3-4
days after it.
The therapy of hemorrhages must be prolonged for at
least 24 hours after manifestations have disappeared.
In hematuria, especially when this is not accompanied
by any other hemorrhagic manifestations, reduce the
doses to prevent formation of clots in the urinary tract.
Xamic ® must not be used in serious renal insufficiency
or anuric syndromes, and must only be used with
caution in less serious renal dysfunctions.
The administration of the product requires particular care
in cardiopathic and hepatopathic subjects. Since the
transplacentary passage of the drug and its possible
effects on the foetus are unknown, Xamic ® should not
be administered during known or presumed pregnancy.
SIDE EFFECTS:
Xamic ® is generally well tolerated; there may be
infrequent cases of sense of fatigue, conjunctival
irritation, nasal blockage, itching, skin reddening,
exanthems.
After oral administration there may be sign of nausea,
diarrhoea, gastric pyrosis.
There are rare case of postural hypotension.
In the case of hypersensitivity to tranexmic acid, avoid or
suspend treatment and start a suitable therapy.
CONTRAINDICATIONS:
Known individual hypersensitivity to the product.
Thromboembolic disease, arterial and venous
thrombosis. Endocavitary hemorrhages. Serious kidney
failure.
STORAGE CONDITION:
Store in a cool (below 300 c) and dry place. Protect from
light. Keep out of the reach of children.
HOW SUPPLIED:
Xamic ® capsule : Each box contains 2 x 10’s capsules
in blister pack.
Xamic ® injection : Each box contains 1 x 5’s ampoules.
Trade Mark
Manufactured by
Renata Limited
Mirpur, Dhaka, Bangladesh